As is known, the preparation of liquid pharmaceutical compositions to be administered to patients is carried out typically by medical or pharmaceutical operators in appropriate sterilized/decontaminated rooms using doses, i.e., preset amounts/weights of one or more active principles prescribed in a medical prescription.
In particular, the operator prepares the liquid pharmaceutical composition by carrying out the following operations: selecting and taking from a store the vials containing the active principles present in the medical prescription; drawing from the vials, using sterile syringes, the preset doses of active principles; and fitting each syringe to the administration instrument to introduce therein the dose of active principle drawn in.
Since it is performed in a completely manual way, the preparation of the liquid pharmaceutical composition described above may be subject to accidental errors, i.e., ones deriving from incorrect aspiration/dosage of the active principles in the syringes by the operator, this latter condition possibly evidently determining pharmaceutical compositions that are potentially harmful/dangerous for the patient.
In order to reduce the aforesaid risks of error, there has been devised digital assistant appliance for assisting the operator in the different steps of manual preparation of the pharmacological composition, which basically comprises: a user interface, through which the operator imparts selection commands of a pre-stored medical prescription and which displays to the operator himself, step by step, messages indicating the operations to be performed; a gravimetric control device for measuring the weight of the vials containing the active principles and the sterile syringes used for transfer of the active principle; and an electronic processing unit, which, on the basis of the weights of the vials and of the syringes, measured before and after the transfer of the active principle from the vials to the syringes, calculates the effective dose of active principle drawn in/dosed by the operator to point out any possible discordance between the dose of active principle effectively drawn in and the dose prescribed in the medical prescription.
The digital assistant appliance of the type described above presents a series of technical drawbacks.
In the first place, the weighing carried out by the gravimetric control device can be affected by errors caused by a modification of the configuration of the vial and/or of the syringe in the course of the weighing operations. It may happen in fact that, during preparation, the operator without realizing applies/removes the lid on/from the vial and/or the needle on/from the syringe and/or the protective cap of the needle on/from the syringe itself and/or a spike, thus modifying the weight measurement conditions, and consequently causing an incorrect calculation of the effective dose of active principle drawn into the syringe.
In the second place, the digital assistant appliance of the type described above considers implicitly correct the operation of selection of the vial containing the active principle by the operator and consequently is not able to detect conditions of selection of vials containing incorrect active principles.
Furthermore, the digital assistant appliance of the type described above presents the technical drawbacks of forcing the operator to choose for each active principle a preset vial and a preset syringe, this latter condition possibly preventing preparation of a liquid pharmaceutical composition when, for example, there occurs the absence of the vial and/or of the syringe envisaged in the procedure implemented by the equipment itself.